- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00826150
Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer
Phase 1/2a, Dose-Escalation, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Intraperitoneal Administration of DTA-H19 in Subjects With Advanced Stage Ovarian Cancer
Panoramica dello studio
Descrizione dettagliata
This is a Phase 1/2a, open label, dose escalation, repeat dose study in 11 subjects with recurrent, platinum resistant advanced stage ovarian cancer or primary peritoneal carcinoma designed to determine the tolerability, safety, quality of life, PK, and preliminary efficacy of DTA-H19 administered intraperitoneally(IP).
Primary Objective: The primary objectives of this study are:
- To determine the maximum tolerated dose (MTD) of IP DTA-H19; and,
- To identify any dose limiting toxicities (DLTs).
Secondary Objectives: Secondary objectives of this study are:
- To determine quality of life of subjects with advanced ovarian cancer, primary peritoneal carcinoma treated with IP DTA-H19;
- To determine the the reduction in malignant ascites as measured by Ultrasound and change in frequency of parecenteses necessary.
- To determine the overall survival distribution.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
-
Holon, Israele
- The Edith Wolfson Medical Center
-
Jerusalem, Israele
- Hadassah University Hospital
-
Kfar Saba, Israele
- Meir Hospital
-
Tel Hashomer, Israele
- Sheba Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Provide written informed consent and be at least 18 years of age.
- Have histopathologically documented epithelial ovarian carcinoma or primary peritoneal carcinoma with evidence of ascites.
- Have either a) platinum-refractory disease (i.e. persistent disease following completion of platinum-based primary chemotherapy) and have failed at least primary platinum-based chemotherapy; or b) platinum-resistant recurrent disease and have failed at least one regimen of second line chemotherapy.
- Be able to tolerate placement of IP catheter.
- Be at least 2 weeks from last treatment to allow recovery from prior toxicity but in the judgment of the investigator with sufficient time to ensure that the effects of prior treatments will not confound safety evaluations.
- Have a Karnofsky performance status score of ≥ 70%.
- Not be of child-bearing potential.
- Have a life expectancy of ≥ 3 months.
- Have serum creatinine < 2.0 mg/dL, total bilirubin less than the institution's 3x upper limit of normal (ULN); AST and ALT <= 2.5 x ULN,total albumin ≥ 2.5 g/dL, PT, PTT, and PT/INR within normal limits, absolute neutrophil count (ANC) > 1,500 x 103 cells/mL, platelets ≥ 100,000/mL, and hemoglobin ≥ 10 mg/dL.
- Have a biopsy specimen or an ascites fluid that is positive for H19 expression.
- Have screening procedures completed within 6-weeks before starting treatment.
- No significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina or congestive heart failure.
- - No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol.
Exclusion Criteria:
- Have evidence of extra abdominal disease with the exception of isolated small nodules (e.g., liver or pulmonary nodules) that are not causing symptoms.
- Have known brain metastases.
- Have known HIV infection.
- Have known active viral or bacterial infections.
- Have presence of any psychological, familiar, sociological, or geographical condition potentially hampering compliance with the study protocol or follow up schedule.
- Have a medical condition contraindicated for laparotomy, laparoscopy, or surgery.
- Have significant bowel involvement denoted by persistent grade 3 vomiting (≥6 episodes in 24 hrs; IV fluids, or total parenteral nutrition (TPN) indicated ≥24 hrs) after removal of ascites, inability to tolerate oral diet or medications, requirement for total parenteral nutrition, or recent (past six weeks) episode of bowel obstruction.
- Have a history of coagulopathy.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: BC-819
BC-819 60, 120 and 240 mg IP administration
|
Cohort #1: 60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. Cohort #2: 120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. Cohort #3: 240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Participants With Dose-Limiting Toxicities
Lasso di tempo: 8 weeks
|
A dose limiting toxicity (DLT) was defined as any grade 3 or greater non-hematologic AE by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
If one subject in a cohort experienced a DLT, then three additional subjects had to be enrolled to that cohort unless a second subject in that cohort experiences a DLT.
The next lower dose was to be considered the MTD.
|
8 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Overall Survival in ITT Population
Lasso di tempo: 17.5 months
|
Overall survival, defined as the time from the start of treatment until the subject died, was estimated by Kaplan Meier curves.
|
17.5 months
|
Solid Tumor Response
Lasso di tempo: 6 weeks
|
If measurable disease was present, then the response of each marker lesion was evaluated separately and rated for response according to RECIST criteria for solid tumors. Complete Response: Disappearance of the target lesion. Partial Response: At least a 30% decrease in the longest diameter of the target lesion. Stable Disease: No sufficient shrinkage to qualify for partial response, or sufficient increase to qualify for progressive disease. Progressive Disease: At least a 20% increase in the longest diameter of the target lesion. |
6 weeks
|
Systemic BC-819 Pharmacokinetics (PK) by Treatment - T1/2 (Hours)
Lasso di tempo: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
|
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
|
Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
|
Systemic BC-819 Pharmacokinetics (PK) - Maximum Observed Plasma Concentration (Cmax)
Lasso di tempo: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
|
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
|
Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
|
Systemic BC-819 Pharmacokinetics (PK) by Treatment - Tmax (Hours)
Lasso di tempo: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
|
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
|
Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
|
Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUClast
Lasso di tempo: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
|
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
|
Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
|
Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUCinf
Lasso di tempo: Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
|
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
|
Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
|
Overall Survival in PP
Lasso di tempo: 17.5 months
|
Overall survival, defined as the time from the start of treatment until the subject died, was estimated by Kaplan Meier curves.
|
17.5 months
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Tally Levy, M.D., The Edith Wolfson Medical Center
- Investigatore principale: David Edelman, MD, Hadassah University Hospital
- Investigatore principale: Ami Fishman, MD, Meir Medical Center
- Investigatore principale: Eitan Rami, MD., Rabin Medical Center
- Investigatore principale: Ofer Lavie, M.D., Carmel Medical Center
- Investigatore principale: Ronnie Shapira-Frommer, MD, Sheba Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie urogenitali
- Neoplasie per sede
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie genitali, femmina
- Malattie del sistema endocrino
- Malattie ovariche
- Malattie annessiali
- Disturbi gonadici
- Neoplasie delle ghiandole endocrine
- Neoplasie ovariche
- Carcinoma, epiteliale ovarico
Altri numeri di identificazione dello studio
- BC-08-01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro ovarico
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
-
Novartis PharmaceuticalsAttivo, non reclutanteEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaTaiwan, Stati Uniti, Olanda, Spagna, Corea, Repubblica di, Italia, Giappone, Canada, Singapore
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di
-
Jonsson Comprehensive Cancer CenterNon ancora reclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Rashmi Verma, MDNational Cancer Institute (NCI)ReclutamentoCarcinoma prostatico resistente alla castrazione | Adenocarcinoma prostatico metastatico | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Assiut UniversityNon ancora reclutamentoDeterminare l’incidenza cumulativa di AKI utilizzando i criteri KDIGO in pazienti pediatrici con tumori maligni presso il South Egypt Cancer Institute (SECI)
-
University of ChicagoNational Cancer Institute (NCI)CompletatoAdenocarcinoma pancreatico | Adenocarcinoma gastrico | Adenocarcinoma pancreatico metastatico | Neoplasia gastrointestinale maligna | Cancro al pancreas in stadio III | Cancro al pancreas in stadio IV | Carcinoma della cistifellea | Cancro alla cistifellea in stadio IV | Cancro gastrico in stadio IV | Cancro... e altre condizioniStati Uniti
Prove cliniche su BC-819
-
Anchiano Therapeutics Israel Ltd.CompletatoCancro della vescica superficialeIsraele, Stati Uniti
-
Anchiano Therapeutics Israel Ltd.TerminatoPancreas, AdenocarcinomaIsraele, Stati Uniti
-
Anchiano Therapeutics Israel Ltd.CompletatoCarcinoma a cellule transizionali della vescicaIsraele
-
FAScinate Therapeutics Inc.ParexelAttivo, non reclutanteMorbo di ParkinsonStati Uniti
-
Kainos Medicine Inc.Completato
-
Kainos Medicine Inc.ParexelReclutamentoAtrofia multisistemicaCorea, Repubblica di
-
Anchiano Therapeutics Israel Ltd.CompletatoNeoplasie pancreaticheStati Uniti, Israele
-
Johnson & Johnson Vision Care, Inc.Completato
-
Cifarma Cientifica Farmaceutica LtdaSconosciuto
-
Coopervision, Inc.Completato